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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06465875
Other study ID # 2024/147
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date December 31, 2024

Study information

Verified date June 2024
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was planned to investigate the effect of reading aloud books on comfort, hope, anxiety and vital signs in patients hospitalized in intensive care unit. This study was designed as a randomized controlled clinical trial. Data will be collected by using the Descriptive Characteristics Questionnaire, General Comfort Scale, Dispositional Hope Scale, State-Trait Anxiety Inventory, and the Vital Signs Monitoring Form.


Description:

This study was planned to investigate the effect of reading aloud books on comfort, hope, anxiety and vital signs in patients hospitalized in intensive care unit. This study was designed as a randomized controlled clinical trial. Data will be collected by using the Descriptive Characteristics Questionnaire, General Comfort Scale, Dispositional Hope Scale, State-Trait Anxiety Inventory, and the Vital Signs Monitoring Form. Individuals in the intervention group will be read a storybook for 3 nights in the intensive care unit. The control group will not be subjected to any practice other than the routine practices of the clinic.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date December 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Over 18 years of age, 2. Stable clinical condition after intensive care unit admission, 3. Have no physical or mental impairment in answering the questions, 4. No verbal communication disability (hearing and speech), 5. No diagnosed psychiatric disorder, 6. With a Glasgow Coma Scale score of 15, 7. Not receiving sedation for at least 12 hours, 8. Will be hospitalized for at least 3 days from the time of enrollment in the study, 9. Individuals who agree to participate in the study will be included in the study. Exclusion Criteria: 1. People with hearing or vision problems, 2. Intubated, 3. Any diagnosed neurological or psychological disorder, 4. Transferred to another unit or exitus before the specified period, 5. Individuals who do not agree to participate in the study will not be included in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Reading a book
Individuals in the intervention group will be read a storybook for three nights.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Outcome

Type Measure Description Time frame Safety issue
Primary Comfort level to be evaluated with the General Comfort Scale It was developed to assess the comfort level of patients. The scale consists of three levels: relief, relaxation and superiority and four dimensions: physical, psychospiritual, sociocultural and environmental. After reading the book of the 3rd day
Primary Level of hope to be assessed with the Dispositional Hope Scale It was conducted to evaluate individuals' hope levels. It is an eight-point Likert type scale consisting of 12 items. Scores from the scale vary between 8 and 64. After reading the book of the 3rd day
Primary Anxiety level to be assessed with State-Trait Anxiety Inventory The inventory was developed to determine the state and trait anxiety levels of individuals. The scale consists of 40 items in total. While the first 20 items measure the state anxiety level, the items from 21 to 40 measure the trait anxiety level of the individual. The total score value obtained from both parts varies between 20 and 80. After reading the book of the 3rd day
Secondary Blood pressure to be assessed with monitor The patient's blood pressure will be measured from the brachial artery with a bedside monitor and the result will be recorded in mmHg. After reading the book of the 3rd day
Secondary Pulse to be assessed with monitor Heart rate will be measured with a bedside monitor that can be measured from a finger and recorded as beats/min. After reading the book of the 3rd day
Secondary Oxygen saturation to be assessed with Pulse Oximeter Oxygen saturation from the finger will be measured and recorded with a Pulse Oximeter. After reading the book of the 3rd day
Secondary Pain to be assessed with Numeric Rating Scale The number "0" on the scale means that they do not feel any pain and the number "10" refers to the worst pain. After reading the book of the 3rd day
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